Treatment for Vancomycin

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Vancomycin+3 More
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two different treatments for recurrent Clostridium difficile infection, to see which is more effective.

Eligible Conditions
  • Vancomycin
  • Clostridium
  • C. Difficile
  • Fidaxomicin

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 7 Secondary · Reporting Duration: Day 90 since randomization

Day 59
Determine symptom resolution during treatment without any of the following: diarrhea recurrence; other non-fatal clinical events including severe abdominal pain, toxic megacolon, and colectomy; and death.
Day 59 since randomization
Sustained clinical response (CDI-COM)
Sustained clinical response (D-COM)
Day 90 since randomization
C.diff Health Related Quality of Life (HRQOL)
CDI Composite outcome measure
Diarrhea Composite outcome measure
Diarrhea recurrence
Symptom resolution

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

0 Treatment Group

549 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 4

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 90 since randomization

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,485 Previous Clinical Trials
2,741,670 Total Patients Enrolled
Stuart B. Johnson, MD BAStudy ChairEdward Hines Jr. VA Hospital, Hines, IL
Dale N Gerding, MDStudy ChairEdward Hines Jr. VA Hospital, Hines, IL

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
At least one of the previous CDI episodes must have been confirmed by a stool assay for C

Who else is applying?

What state do they live in?
Arizona100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

How responsive is this trial?

Typically responds via
Phone Call100.0%